GPP2’s recommendations [1], when considered in their entirety and in
conjunction with GPP2’s checklists, will help authors, contributors and
sponsors to collaborate responsibly and appropriately.
GPP2 agrees with Poses [2], Jacobs and Baldwin [3] that guest and
ghost authors are unacceptable. GPP2 requires “Honest attribution of
authorship” [1]. ‘Who did the work?’ should be answered by an honest list
of all authors and acknowledged contributors. All qualifying authors and
contributors should be listed, including contributing individuals employed
or contracted by the sponsor. Contributorship statements to describe
exactly who did what should be used.
We disagree with Poses that the GPP2 guidelines “obfuscate who is
responsible and accountable for a clinical trial.”
GPP2 states “Authors … are responsible for how medical research is
interpreted and communicated” [1]. GPP2 reflects ICMJE guidance that “Each
author should have participated sufficiently in the work to take public
responsibility for appropriate portions of the content” [4]. GPP2
recommends that investigators as well as “members of the study steering
committee and the protocol development team” [1] (i.e. the principal
investigators or individuals who designed the study) should comprise the
publication steering committee. GPP2 states “members of the publication
steering committee may become authors, but membership of the committee
does not automatically confer authorship” [1] because authorship should
depend on actual contributions made to the publication.
GPP2’s recommendation for a named “guarantor” reflects ICMJE guidance
[4]. One of the principal investigators would likely be guarantor and
probably lead author on at least the primary publication(s) from a study.
In the US, Europe and elsewhere sponsors are now legally required or
obliged to post clinical trial results on a publicly-accessible internet
registry regardless of outcome [5,6]. Particularly for these trials GPP2
recommends “Making public or publishing results regardless of outcome”
[1]. Sponsors should endeavour to publish, to avoid publication bias from
unpublished negative results.
References
1. Graf C, Battisti WP, Bridges D et al. Good publication practice
for communicating company sponsored medical research: the GPP2 guidelines.
BMJ 2009;339:b4330
6. International Federation of Pharmaceutical Manufacturers and
Associations, European Federation of Pharmaceutical Industries and
Associations, Japan Pharmaceutical Manufacturers Association,
Pharmaceutical Research and Manufacturers of America. Joint position on
the disclosure of clinical trial information via clinical trial registries
and databases. Updated November 10, 2009.
Competing interests:
The authors' competing interests are disclosed in full in GPP2 (BMJ 2009;339:b4330).
Competing interests:
No competing interests
12 January 2010
Chris Graf
Lead author, GPP2 guidelines
Wendy P Battisti, Dan Bridges, Victoria Bruce-Winkler, Joanne M Conaty, John M Ellison, Elizabeth A Field, James A Gurr, Mary-Ellen Marx, Mina Patel, Carol Sanes-Miller, Yvonne E Yarker, Jane Moore, John Draper, members of ISMPP GPP2 Steering Committee
John Wiley & Sons, Wiley-Blackwell, Oxford OX4 2DQ
Rapid Response:
Debating good publication practice
GPP2’s recommendations [1], when considered in their entirety and in
conjunction with GPP2’s checklists, will help authors, contributors and
sponsors to collaborate responsibly and appropriately.
GPP2 agrees with Poses [2], Jacobs and Baldwin [3] that guest and
ghost authors are unacceptable. GPP2 requires “Honest attribution of
authorship” [1]. ‘Who did the work?’ should be answered by an honest list
of all authors and acknowledged contributors. All qualifying authors and
contributors should be listed, including contributing individuals employed
or contracted by the sponsor. Contributorship statements to describe
exactly who did what should be used.
We disagree with Poses that the GPP2 guidelines “obfuscate who is
responsible and accountable for a clinical trial.”
GPP2 states “Authors … are responsible for how medical research is
interpreted and communicated” [1]. GPP2 reflects ICMJE guidance that “Each
author should have participated sufficiently in the work to take public
responsibility for appropriate portions of the content” [4]. GPP2
recommends that investigators as well as “members of the study steering
committee and the protocol development team” [1] (i.e. the principal
investigators or individuals who designed the study) should comprise the
publication steering committee. GPP2 states “members of the publication
steering committee may become authors, but membership of the committee
does not automatically confer authorship” [1] because authorship should
depend on actual contributions made to the publication.
GPP2’s recommendation for a named “guarantor” reflects ICMJE guidance
[4]. One of the principal investigators would likely be guarantor and
probably lead author on at least the primary publication(s) from a study.
In the US, Europe and elsewhere sponsors are now legally required or
obliged to post clinical trial results on a publicly-accessible internet
registry regardless of outcome [5,6]. Particularly for these trials GPP2
recommends “Making public or publishing results regardless of outcome”
[1]. Sponsors should endeavour to publish, to avoid publication bias from
unpublished negative results.
References
1. Graf C, Battisti WP, Bridges D et al. Good publication practice
for communicating company sponsored medical research: the GPP2 guidelines.
BMJ 2009;339:b4330
2. http://www.bmj.com/cgi/eletters/339/nov27_1/
b4330#226987
3. http://www.bmj.com/cgi/eletters/339/nov27_1/
b4330#227612
4. International Committee of Medical Journal Editors. Uniform
requirements for manuscripts submitted to biomedical journals.
www.icmje.org.
5. Food and Drug Administration Amendments Act of 2007.
www.fda.gov/RegulatoryInformation/Legislation/Federal
FoodDrugandCosmeticActFDCAct/SignificantAmendmentsto
theFDCAct/FoodandDrugAdministrationAmendmentsActof2007
/default.htm
6. International Federation of Pharmaceutical Manufacturers and
Associations, European Federation of Pharmaceutical Industries and
Associations, Japan Pharmaceutical Manufacturers Association,
Pharmaceutical Research and Manufacturers of America. Joint position on
the disclosure of clinical trial information via clinical trial registries
and databases. Updated November 10, 2009.
http://clinicaltrials.ifpma.org/fileadmin/files/pdfs/EN/
November_10_2009_Updated_Joint_Position_on_the_Disclosure
_of_Clinical_Trial_Information_via_Clinical_Trial_
Registries_and_Databases.pdf
Competing interests:
The authors' competing interests are disclosed in full in GPP2 (BMJ 2009;339:b4330).
Competing interests: No competing interests